Overview

This trial is active, not recruiting.

Conditions posttraumatic stress disorder (ptsd), depression
Treatments steps up, ouc
Phase phase 3
Sponsor Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborator United States Department of Defense
Start date January 2012
End date October 2014
Trial size 666 participants
Trial identifier NCT01492348, W81XWH-09-2-0077

Summary

The overall objective of this study is to test the effectiveness of a systems-level approach to primary care recognition and management of PTSD and depression in the military health system. More specifically, the investigators will test the effectiveness of a telephone care management with preference-based stepped PTSD/depression care--STepped Enhancement of PTSD Services Using Primary Care (STEPS UP)--as compared to Optimized Usual Care (OUC).

Primary Hypothesis 1: Active duty primary care patients with PTSD, depression, or both who are randomly assigned to STEPS UP will report significantly greater reductions in PTSD and depression symptom severity compared to participants assigned to OUC over 12-months of follow-up.

Hypothesis 2: Active duty primary care patients with either PTSD, depression, or both who are randomly assigned to STEPS UP will report significantly greater improvements in somatic symptom severity, alcohol use, mental health functioning, and work functioning compared to participants assigned to OUC over 12-months of follow-up.

Hypothesis 3: The STEPS UP program will be both more costly and more effective compared to OUC over the 12-months of follow-up, and will have a favorable cost-effectiveness ratio in terms of dollars per quality adjusted life years saved.

Hypothesis 4: Active duty primary care patients participating in STEPS UP, their clinicians, care managers, and family members will report that STEPS UP is acceptable, effective, satisfying, and appropriate PTSD and depression care.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
STEPS UP is a centrally assisted stepped collaborative telecare management program within primary care. The STEPS UP intervention added to Optimized Usual Care (PCMH-BH; formerly RESPECT-Mil) in 4 ways: (1) care management enhancements; (2) stepped psychosocial treatment options (web, phone, in person); (3) electronic symptom registry for measurement-based treatment planning (symptoms are measured at regular intervals and care is intensified for patients with recurrent or persistent PTSD and/or depressive) and for telecare manager caseload and site performance monitoring; and (4) routine assisted review of patient, telecare manager, and site performance by a central psychiatrist and psychologist.
steps up
The STEPS UP intervention enhances RESPECT-Mil in several ways: Adds care manager training in motivational enhancement, problem solving, and behavioral activation strategies to improve patient engagement. Adds preference-based stepped care (i.e., order of steps determined by symptom severity, patient preference, & primary care recommendation) to existing options of pharmacotherapy that includes web-based self-management programs; flexible, modularized telephone-delivered CBT; and individual face to face psychotherapy by specialist. Adds option for centralized, telephone-based care management to improve fidelity of intervention delivery, continuity of care, and access to care during off-hours. Adds a centralized care team using an electronic symptom registry to provide staffing to care managers, track patients longitudinally, develop stepped-based treatment recommendations, and monitor intervention components.
(Active Comparator)
Service members randomized to Optimized Usual Care (OUC) will get usual treatment at the site. OUC is RESPECT-Mil, a voluntary, primary care-based implementation program where, with the assistance and collaboration of a psychiatrist and an on-site nurse-level care manager, service members with symptoms of PTSD and depression are screened, tracked, and treated within the primary care system.
ouc
Service members randomized to Optimized Usual Care (OUC) will get usual treatment at the site. OUC is RESPECT-Mil, a voluntary, primary care-based implementation program based on the "three-component model" where, with the assistance and collaboration of a psychiatrist and an on-site nurse-level care manager, service members with symptoms of PTSD and depression are screened, tracked, and treated within the primary care system. Components of the RESPECT-Mil program include (1) equipping and training primary care clinics to screen each visit and use symptom severity tools for diagnosis and assessment; (2) using nurse care managers to assist patients and primary care clinicians; and (3) increasing access to a mental health specialist, often using a clinic specialist.

Primary Outcomes

Measure
Posttraumatic Diagnostic Scale (PDS)
time frame: baseline - 3 months
Posttraumatic Diagnostic Scale (PDS)
time frame: baseline - 6 months
Posttraumatic Diagnostic Scale (PDS)
time frame: baseline - 12 months
Hopkins Symptom Checklist Depression Scale-20 Item Version (HSCL-20)
time frame: baseline - 3 months
Hopkins Symptom Checklist Depression Scale-20 Item Version (HSCL-20)
time frame: baseline - 6 months
Hopkins Symptom Checklist Depression Scale-20 Item Version (HSCL-20)
time frame: baseline - 12 months

Secondary Outcomes

Measure
Somatic Symptom Severity - Patient Health Questionnaire - 15 (PHQ-15)
time frame: baseline - 3 months
Somatic Symptom Severity - Patient Health Questionnaire - 15 (PHQ-15)
time frame: baseline - 6 months
Somatic Symptom Severity - Patient Health Questionnaire - 15 (PHQ-15)
time frame: baseline - 12 months
Alcohol Use Disorders Identification Test (AUDIT)
time frame: eligibility - 3 months
Alcohol Use Disorders Identification Test (AUDIT)
time frame: eligibility - 6 months
Alcohol Use Disorders Identification Test (AUDIT)
time frame: eligibility - 12 months
Health-Related Quality of Life and Functional Status - Medical Outcomes Study Short Form-12 (SF-12)
time frame: baseline - 3 months
Health-Related Quality of Life and Functional Status - Medical Outcomes Study Short Form-12 (SF-12)
time frame: baseline - 6 months
Health-Related Quality of Life and Functional Status - Medical Outcomes Study Short Form-12 (SF-12)
time frame: baseline - 12 months
WHO Health and Work Performance Questionnaire—Short Form (HPQ-SF)
time frame: baseline - 3 months
WHO Health and Work Performance Questionnaire—Short Form (HPQ-SF)
time frame: baseline - 6 months
WHO Health and Work Performance Questionnaire—Short Form (HPQ-SF)
time frame: baseline - 12 months
Numeric Rating Scale for Pain
time frame: baseline - 3 months
Numeric Rating Scale for Pain
time frame: baseline - 6 months
Numeric Rating Scale for Pain
time frame: baseline - 12 months

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - Active duty status at the time of enrollment - Positive PTSD screen (2 or more yes responses on PC-PTSD), per routine primary care screening. - DSM-IV-TR criteria for A) PTSD using the PCL-C (i.e.., a "moderate" or greater severity level on 1 re-experiencing, 3 avoidance, and 2 hyperarousal symptoms) and/or B) Depression, using the PHQ-9 (i.e., endorsement of at least 5 of the 9 symptoms experienced "more than half the days" and at least one of those symptoms must include either "little interest or pleasure in doing things" or "feeling down, depressed or hopeless") - Report of routine computer, Internet, and e-mail access - Capacity to consent to participation and provide research informed consent using local IRB-approved form Exclusion Criteria: - Treatment refractory PTSD or depression after participation in RESPECT-mil or specialty mental health treatment. - Acute psychosis, psychotic episode, or psychotic disorder diagnosis by history within the past 2 years - Bipolar I disorder by history or medical record review within last 2 years. - Active substance dependence disorder in the past year by history within the past 12 months. - Active suicidal ideation within the past 2 months by history. - Patients on psychoactive medication, unless that medication dosing and administration has been stable and regular for at least 1 month. - Acute or unstable physical illness. - Anticipated deployment, demobilization, or separation during the next six months. - Personnel who work in participating clinics.

Additional Information

Official title Stepped Enhancement of PTSD Services Using Primary Care (STEPS UP): A Randomized Effectiveness Trial
Principal investigator Robert M Bray, PhD
Description Despite the significant prevalence of posttraumatic stress disorder (PTSD) and depression among veterans returning from Operations in Iraq and Afghanistan, less than half of service members who are referred for a specialty mental health assessment actually receive specialty mental health treatment. Systematic knowledge regarding access to care and quality of care delivered in civilian, VA, and military facilities for those who encounter barriers or difficulty is scant, and recent policy reviews have strongly questioned availability and quality of care. These problems of access and quality are major, overarching problems in war-related PTSD research. There are scientifically tested strategies from non-military settings and for other mental disorders to improve access to and quality of care; unfortunately, these strategies are unstudied in the military health system and for PTSD and depression. These strategies include care manager coordination (connecting patient, provider, and specialist), collaborative care (negotiated patient-provider problem definition, monitoring of status and treatment response, self-management support, telehealth sustained follow-up), and stepped care (logical, patient-centered and guideline-concordant treatment sequencing). This study aims to fill these gaps and evaluate these systems-level strategies in a military setting for PTSD and depression. The purpose of the STEPS UP (STepped Enhancement of PTSD Services Using Primary Care) trial is to compare centralized telephonic care management with preference-based stepped PTSD and depression care to optimized usual care. We hypothesize that the STEPS UP intervention will lead to improvements in (1) PTSD and depression symptom severity (primary hypothesis); (2) somatic symptom severity, alcohol use, mental health functioning, work functioning; (3) costs and cost-effectiveness. We further hypothesize that qualitative data obtained from interviews will show that (4) patients, their family members, and participating clinicians find the STEPS-UP intervention to be an acceptable, effective, and satisfying approach to deliver and receive PTSD and depression care. STEPS-UP is a six-site, two-parallel arm (N = 666) randomized controlled effectiveness trial with 3-month, 6-month, and 12-month follow-up comparing centralized telephonic stepped-care management to optimized usual PTSD and depression care. In addition to the existing PTSD and depression treatment options, STEPS UP includes web-based cognitive behavioral self-management, telephone cognitive-behavioral therapy, continuous RN nurse care management, and computer-automated care management support. Both arms can refer patients for mental health specialty care as needed, preferred and available. The study uses sites currently running RESPECT-Mil, the existing military primary care-mental health services practice network, to access site health care leaders and potential study participants at the 6 study sites. If effective, we expect that STEPS UP will increase the percentage of military personnel with unmet PTSD- and depression-related health care needs who get timely, effective, and efficient PTSD and depression care. Our real-world primary care effectiveness emphasis will prevent the Institute of Medicine's so called "15 year science to service gap." If successful, STEPS UP could roll out immediately, reinforcing and facilitating pathways to PTSD and depression recovery.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Henry M. Jackson Foundation for the Advancement of Military Medicine.